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Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

NCT ID: NCT03487250

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-04

Study Completion Date

2019-04-20

Brief Summary

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To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.

Detailed Description

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This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.

Conditions

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Elbow, Tennis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TenJet System

Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

TenJet System

Intervention Type DEVICE

Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

Interventions

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TenJet System

Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is \> 18 years of age
* Chronic lateral or medial elbow pain \> 3 month duration
* History and clinical examination consistent with lateral or medial epicondylitis
* Sonographic evidence of medial or lateral elbow tendinosis as evidenced by

* tendon thickening and hypoechogenicity,
* with or without hypervascularity on Doppler examination and,
* with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear.
* \> 3 months of non-operative treatment that included

* nonsteroidal anti-inflammatory drugs
* activity modification
* physical therapy
* elbow straps
* With or without previous steroid injections, protein rich plasma injections, or stem cell injections
* Patient is willing and able to provide informed consent and comply with the study protocol

Exclusion Criteria

* Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side)
* Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
* Steroid injection within 4 weeks of the study procedure
* Active local or systemic infection
* Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament.
* Patient is known or suspected to be pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HydroCision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reginald Kapteyn, DO

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Associates of Muskegon

Locations

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Orthopaedic Associates of Muskegon

Muskegon, Michigan, United States

Site Status

Penn Highlands

DuBois, Pennsylvania, United States

Site Status

Noble Pain Management & Sports Medicine

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PUGET-01-016

Identifier Type: -

Identifier Source: org_study_id